MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sore Throat (2396)

Event Date 11/02/2015

Event Type  Injury  

Event Description

It was reported that a patient, recently implanted with vns system, had pain and hoarseness.The patient was stating that it was tight and hurting a lot.It was reported that the patient was seen by a nurse and her physician, where she received antibiotics because the incision looked red.But the patient's throat was sore and her voice was still hoarse.It was reported by the nurse that the device had not been turned on yet, so the pain and soreness was likely a result of the surgery.Further information received indicates that the patient was again seen in clinic and she was doing well; the pain has stopped and her wound was dry.The patient's voice has been settled.It was reported that the device is now turned on.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.The device history records showed that the generator was sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

Additional manufacturer narrative and/or corrected data, corrected data: (b)(4).The suspect device udi was inadvertently not provided in the initial mdr.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5260052
• MDR Text Key: 32456924
• Report Number: 1644487-2015-06622
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 106
• Device Lot Number: 203316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR